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8.22.6 8.22.7 Resource ResearchStudy - Mappings

Regulated Clinical Biomedical Research Information Management and Regulation Work Group

Maturity Level : N/A

Ballot Standards Status : Informative

Security Category : Business

Compartments : Practitioner

Mappings for the researchstudy resource. resource (see Mappings to Other Standards for further information & status).

8.22.6.1 8.22.7.1 Mappings for RIM FiveWs Pattern Mapping (http://hl7.org/v3) ( http://hl7.org/fhir/fivews )

.identifier .outboundRelationship[typeCode=DEFN].target .inboundRelationship[typeCode=COMP].source[moodCode=EVN] .status

ResearchStudy	Observation[classCode=CLNTRL, moodCode=EVN]
identifier	FiveWs.identifier
title     status	FiveWs.status
protocol     focus	FiveWs.what[x]
partOf     condition	FiveWs.what[x]
status     enrollment	FiveWs.subject[x]
category     period	FiveWs.done[x]
focus     sponsor	FiveWs.actor
contact     principalInvestigator	FiveWs.actor
relatedArtifact     site	FiveWs.where[x]
keyword     reasonStopped	FiveWs.why[x]

8.22.7.2 HL7 v2 Mapping ( http://hl7.org/v2 )

8.22.6.2 Mappings for HL7 v2 Mapping (http://hl7.org/v2) ResearchStudy

jurisdiction ResearchStudy	OBX
description     identifier
enrollment     title
period     protocol
sponsor     partOf
principalInvestigator     status
site     primaryPurposeType
reasonStopped     phase
note     category
arm     focus
name     condition
code     contact
description     relatedArtifact
keyword
location
description	OBX
identifier     enrollment
title     period
protocol     sponsor
partOf     principalInvestigator
status     site
category     reasonStopped
focus     note
contact     arm
relatedArtifact         name
keyword         type
jurisdiction         description
description     objective
enrollment         name
period         type

8.22.7.3 RIM Mapping ( http://hl7.org/v3 )

sponsor ResearchStudy	Observation[classCode=CLNTRL, moodCode=EVN]
principalInvestigator     identifier	.identifier
site     protocol	.outboundRelationship[typeCode=DEFN].target
reasonStopped     partOf	.inboundRelationship[typeCode=COMP].source[moodCode=EVN]
note     status	.status
arm     enrollment	.participation[typeCode=SBJ].role
name     period	.effectiveTime
code     sponsor	.participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]
description     note	.inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]

8.22.6.3 8.22.7.4 Mappings for ClinicalTrials.gov Mapping (http://clinicaltrials.gov) ( http://clinicaltrials.gov )

ResearchStudy
identifier	Organization's Unique Protocol ID; Secondary IDs
title	Brief Title
protocol	Interventions; Arm/Intervention Cross-Reference
partOf
status
primaryPurposeType
phase	Study Phase
category	Study Type; Primary Purpose; Study Phase; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
focus	Conditions or Focus of Study
condition	Conditions
contact	Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
relatedArtifact	Citations, Links, Available Study Data/Documents
keyword	Keywords
jurisdiction     location
description	Detailed Description
enrollment	Enrollment; Number of Groups/Cohorts (= number of "enrollment" "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
period	Study Start Date (start); Study Completion Date (end)
sponsor	Sponsor
principalInvestigator	Principal Investigator
site	Facility
reasonStopped	Why Study Stopped
note
arm	Arms
name	Arm Label
code         type	Arm Type
description	Arm Description
objective
name
type

8.22.7.5 BRIDG 5.1 Mapping ( https://bridgmodel.nci.nih.gov )

ResearchStudy	ObservationalStudyProtocolVersion; Study; StudyProtocolVersion
identifier	No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
title	No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
protocol	StudyProtocolDocumentVersionPublicTitle.name
partOf	CompanionStudyRelationship
status	StudyOverallStatus.code
primaryPurposeType	StudyProtocolVersion.primaryPurposeTypeCode
phase	StudyProtocolVersion.phaseCode
category	InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
focus	InterventionalStudyProtocol.interventionTypeCode
condition	StudyCondition.code
contact	PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
relatedArtifact	StudyProtocolDocument, StudyProtocolDocumentVersion
keyword	DocumentVersion.keywordCode; DocumentVersion.keywordText
location	StudyProtocolVersion.participatingLocationCode
description	StudyProtocolDocumentVersion.publicDescription
enrollment	InterventionalStudyProtocol.interventionGroupQuantity
period	ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
sponsor	RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode
principalInvestigator	StudyInvestigator
site	PlannedStudySite; StudySite
reasonStopped	StudyOverallStatus.studyStoppedReasonCode
note	No BRIDG mapping
arm	Arm
name	Arm.name
type	Arm.typeCode
description	Arm.description
objective	StudyObjective
name	No BRIDG mapping (BRIDG has a description, but not a name)
type	StudyObjective.typeCode